Resmed Recalls 42 Quattro Air FFM Masks Due to Sizing and Venting Errors
Resmed is recalling 42 Quattro Air FFM masks labeled as Medium vented but containing Large non-vented masks.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a labeling and product mismatch (size and venting type) without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Resmed Corporation is recalling 42 units of Quattro Air FFM MED AMER full face masks, Product Code 62702. These masks are intended for use with active-exhaust-valve ventilators.
The recall is due to a labeling and product mismatch. The masks in Lot 1142623 were labeled and sold as size Medium vented masks, but they actually contain size Large non-vented (NV) masks. This discrepancy could result in patients receiving the wrong size and type of mask for their ventilator therapy.
The affected units were distributed nationwide in the US. Patients and healthcare providers should stop using these masks and contact Resmed for a replacement or refund.
The recalled product
- Product
- Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
- Manufacturer
- Resmed Corporation
- Affected units
- 42
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 1142623
Distribution
Distributed nationwide across the United States.
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